Success for the EXAM Trial

We recently reported top-line data from the pivotal phase 3 trial of cabozantinib in patients with medullary thyroid cancer (the EXAM trial). Top-line results show a 2.8-fold increase in progression-free survival (PFS) versus placebo. Cabozantinib significantly improved median PFS by 7.2 months compared with placebo. The median PFS on the cabozantinib arm was 11.2 months versus 4.0 months on the placebo arm; hazard ratio (HR) 0.28, (95% CI 0.19, 0.40), p < 0.0001. The success of this trial is a tremendous milestone on multiple fronts, and it brings us closer to achieving our vision of being a commercial biopharmaceutical company that is making a positive difference in the lives of cancer patients.

For patients, the EXAM data bring an important potential therapy one step closer to the market. It has been known for some time that many patients with MTC have unmet medical needs and are not achieving optimal management of their disease. The ability to address those needs and to provide a new treatment option to MTC patients is a very positive motivator to move as quickly as we can through the process of submitting a new drug application (NDA) in MTC to the FDA.

The success of EXAM is also a critical milestone for our company because it marks the first time that a compound discovered and developed internally by Exelixis has progressed to and successfully completed a pivotal trial. This is a tremendous accomplishment that reflects the diligence, dedication, and commitment of all who participated in the discovery and development of cabozantinib. We could not have reached this key step in our evolution without the efforts of our scientific, clinical, and regulatory teams, and everyone at Exelixis who helped to make this work possible.
 
It’s important to recognize that the success of EXAM is a critical cornerstone on which we intend to build a cabozantinib franchise. With positive momentum from our first pivotal trial, we are moving more rapidly toward our goal of creating value for patients and our shareholders.
 
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